Diastolic DysfunctionPhase 4NCT01188369
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
A Phase 4 study testing levosimendan in people with Diastolic Dysfunction and Left Ventricular Hypertrophy, run by University of Aarhus at 1 site in Denmark.
Trial summary
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Diastolic Dysfunction, Left Ventricular Hypertrophy
- What is being tested?
- levosimendan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for aortic valve replacement
- EF > 45%
- Left ventricular posterior wall > 12mm
- Sinus rhythm
Who cannot join
- Concomitant bypass operation
- Severe mitral insufficiency
- Active endocarditis
- Insufficient ultrasound opportunity
- Systolic blood pressure < 100 mmHg
- moderate-severe renal failure
Show all 9Show fewer
- allergy to levosimendan
- lack of patient consent Pregnancy or status of lactating
- Fertile women who do not use relevant anticonception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Levosimendan on Systolic Deformation and Diastolic Function in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.
Read the detailed description
Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:
- Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion
- Immediately before surgery
- After induction of anaesthesia and before "knife time" = start of surgery.
- At the end of surgery: Levosimendan infusion will stop.
- Approximately 4 hours after surgery immediately before extubation.
- Approximately 21 hours after surgery
- Approximately 96 hours after surgery (day 4)
- 6 months after surgery
Outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.
Interim analysis will be conducted after 30 included patients.
- Being tested
- levosimendan, placebo drug
- Keywords
- levosimendan, heart failure, inotropics, diastolic dysfunction, left ventricular hypertrophy, aortic valve stenosis
- Medical subject headings
- Hypertrophy, Left Ventricular, Heart Failure, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
Also called Simdax
Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.
placebo drugDrug
Also called Placebo
Intravenous infusion, colour identical to levosimendan
| Study group | Role | What they receive |
|---|---|---|
| levosimendan | Experimental | infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation Receives: Drug: levosimendan |
| Placebo | Placebo comparator | Identical placebo Receives: Drug: placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
E/E'(Unitless)
Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function
Measured: 4 hours before operation until 21 hour after operation
Secondary outcomes (77)
Isovolumetric Relaxation Time (IVRT) (s)
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Measured: 4 hours before surgery until 1 hour before operation
Ejection Fraction (Per Cent)
Transeosophageal echocardiography: Measure of systolic function
Measured: At start of operation until end of operation, approximately 3 hours
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Measured: 4 hours before operation until 1 hour before operation
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Measured: 4 hours before operation until 1 hours before operation
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Measured: 4 hours before operation until 1 hour before operation
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Measured: 4 hours before operation until 1 hour before operation
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
blood sample reflecting stretch of the atrium/ventricle
Measured: 4 hours before operation until 4 hours after operation
Troponin T (ug/l)
Blood sample expressing damage to the myocytes
Measured: 4 hours before operation until 4 hours after operation
Lactate (mmol/l)
Arterial sampling of blood lactate
Measured: 4 hours before operation until 4 hour after operation
Mixed Venous Oxygenation (Per Cent)
Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery
Measured: 4 hours before operation until 4 hour after operation
E/A Ratio (Unitless)
TEE ratio between early (E) transmitral flow and late (A) transmitral flow. An index of diastolic function althought not validated properly yet when measured from the oesophagus
Measured: At the start of operation until the end of operationon, approximately 3 hours
Regional Longitudinal Strain (Unitless)
Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.
Measured: At the start of operation until the end of operation, approximately 3 hours
Need for Conventional Inotropical Agents
Conventional inotropics are comprised of all inotropics acting primarily through alfa- or beta- stimulation.
Measured: From start of operation until 5 days after operation
Intravenous Fluid Requirement (l)
Total volume of intravenous fluid required including blood products.
Measured: Within 24 hours from start of operation
Operation Time (Minutes)
Measured: From "knife start" until "knife end", approximately 3 hours
Time on Heart-lung Machine (Minutes)
Measured: From time of cardioplegia until selfsufficient cardiac action, approximately 1 hour
Intubation Time (Minutes)
Total time intubated including time of operation and in the intensive care ward
Measured: From intubation until extubation, approximately 6 hours
Postoperative Admission Time at Intensive Care Unit (Hours)
Total admission time in the intensive care after operation
Measured: From admission to the intensive care unit until discharge from intensive care unit, approximately 24 hours
No. of Patients With Adverse Events
Development of Ventricular tachycardia
Measured: -4 hours until + 96 hours with respect to start of operation
No. of Patients With Adverse Event
Development of atrial flutter/fibrillation
Measured: -4 hours until + 96 hours with respect to start of operation
No. of Patients With Adverse Event
Need for norepinephrine as an antagonist to the vasodilatatory effect of levosimendan
Measured: 4 hours before operaton until 1 hour before operaton
No. of Patients With Adverse Event.
Occurence of nausea
Measured: 4 hours before operation until 1 hour before operation
No. of Patients With Adverse Event
Occurence of headache
Measured: 4 hours before operation until approximately 1 hour before operation
Regional Longitudinal Strain (Unitless)
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Measured: 4 hours before until 1 hour before start of operation
Ejection Fraction (Per Cent)
TTE: Index of systolic function
Measured: 1 hour before until 21 hour after start of operation
Ejection Fraction (Per Cent)
TTE: Index of systolic function
Measured: 21 hours after operation until 96 hours after start of operation
Ejection Fraction (Per Cent)
TTE: Index of systolic function
Measured: 96 hours after operation until 6 months after operation
Regional Longitudinal Strain (Unitless)
Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.
Measured: Froml the end of operation until approx 4 hours after operation
E/A Ratio (Unitless)
TEE ratio between early (E) transmitral flow and late (A) transmitral flow. An index of diastolic function althought not validated properly yet when measured from the oesophagus
Measured: At the end of operationon until approx 4 hours after operation
Left Ventricular Rotation (Degrees)
TTE: Index of both systolic and diastolic function
Measured: 96 hour after operation until 6 months after operation
Mixed Venous Oxygenation (Per Cent)
Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery
Measured: 4 hours after operation until 21 hours after operation
Lactate (mmol/l)
Arterial sampling of blood lactate
Measured: 4 hours after operation until 21 hours after operation
Troponin T (ug/l)
Blood sample expressing damage to the myocytes
Measured: 4 hours after operation until 21 hours after operation
Troponin T (ug/l)
Blood sample expressing damage to the myocytes
Measured: 21 hours after operation until 96 hours after operation
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
blood sample reflecting stretch of the atrium/ventricle
Measured: 4 hours after operation until 21 hours after operation
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
blood sample reflecting stretch of the atrium/ventricle
Measured: 21 hours after operation until 96 hours after operation
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Measured: 1 hour before operation until start of operation
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Measured: Start of operation until the end of operation, approximately 3 hours
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Measured: End of operation until approx 4 hours after operation
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Measured: 4 hours after operation until 21 hours after operation
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Measured: 1 hour before operation until start of operation
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Measured: Start of operation until end of operation, approximately 3 hours
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Measured: End of operation until approx 4 hours after operation
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Measured: 4 hours after operation until 21 hours after operation
Regional Longitudinal Strain (Unitless)
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Measured: 1 hour before start of operation until 21 hours after operation
Regional Longitudinal Strain (Unitless)
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Measured: 21 hours after operation until 96 hours after operation
Regional Longitudinal Strain (Unitless)
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Measured: 96 hours after operation until 6 months after operation
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Measured: 1 hour before operation until start of operation
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Measured: Start of operation until end of operation, approximately 3 hours
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Measured: End of operation until approx 4 hours after operation
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Measured: 4 hours after operation until 21 hours after operation
Peak Systolic Velocity (m/s)
Tissue Doppler measure of systolic function
Measured: 1 hour before operation until 21 hours after operation
Peak Systolic Velocity (m/s)
Tissue Doppler measure of systolic function
Measured: 21 hours after operation until 96 hours after operation
Peak Systolic Velocity (m/s)
Tissue Doppler measure of systolic function
Measured: 96 hours after operation until 6 months after operation
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Transthoracic echocardiographic measure of systolic function
Measured: 1 hour before operation until 21 hours after operation
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Transthoracic echocardiographic measure of systolic function
Measured: 21 hours after operation until 96 hours after operation
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Transthoracic echocardiographic measure of systolic function
Measured: 96 hours after operation until 6 months after operation
E/A-ratio (Unitless)
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
Measured: 1 hour before operation until 21 hours after operation
E/A-ratio (Unitless)
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
Measured: 21 hours after operation until 96 hours after operation
E/A-ratio (Unitless)
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
Measured: 96 hours after operation until 6 months after operation
E'/A'-Ratio (Unitless)
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
Measured: 1 hour before operation until 21 hours after roperation
E'/A'-Ratio (Unitless)
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
Measured: 21 hours after operation until 96 hours after operation
E'/A'-Ratio (Unitless)
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
Measured: 96 hours after operation until 6 months after operation
Isovolumetric Relaxation Time (IVRT) (s)
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Measured: 1 hour before operation until 21 hours after operation
Isovolumetric Relaxation Time (IVRT) (s)
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Measured: 21 hours after operation until 96 hours after operation
Isovolumetric Relaxation Time (IVRT) (s)
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Measured: 96 hours after operation until 6 months after operation
Ejection Fraction (Per Cent)
Transeosophageal echocardiography: Measure of systolic function
Measured: End of operation until approx. 4 hours after operation
Isovolumetric Relaxation Time (IVRT) (s)
Transeosophageal echocardiography: Time from closure of aortic valve to opening of mitral valve. Measure of diastolic function.
Measured: End of operation until approx. 4 hours after operation
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Measured: 1 hour before operation until start of operation
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Measured: Start of operation until end of operation, approximately 3 hours
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Measured: End of operation operation until approx. 4 hours after operation
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Measured: 4 hours after operation until 21 hours after operation
Inflammatory Parameters
Blood sample values of pro- and antiinflammatory mediators
Measured: 4 hours before operation until 21 hours after operation
Inflammatory Parameters
Blood sample values of pro- and antiinflammatory mediators
Measured: 21 hours after operation until 96 hours after operation
E/A-ratio (Transoesophageal)
Transoesophageal echocardiographic measure of diastolic heart function
Measured: from start of operation until end of operation, approximately 3 hours
E/A-ratio (Transoesophageal)
Transoesophageal echocardiographic measure of diastolic heart function
Measured: from end of operation until approximately 4 hours after operation
Urine Clearance
Urine analysis. Measure of kidney function.
Measured: from start of operation until 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Terminated prematurely due to high incidence of postoperative atrial fibrillation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Juhl-Olsen, M.D., Principal investigator, Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188369
- Sponsor's protocol ID
- 1616
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2010
- Last updated
- 3 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Levosimendan on Systolic Deformation and Diastolic Function in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
- ClinicalTrials.gov ID
- NCT01188369
- Acronym / sponsor ID
- 1616
- Keywords
- levosimendan, heart failure, inotropics, diastolic dysfunction, left ventricular hypertrophy, aortic valve stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated prematurely due to high incidence of postoperative atrial fibrillation.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Posted 3 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.
Detailed description
Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:
- Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion
- Immediately before surgery
- After induction of anaesthesia and before "knife time" = start of surgery.
- At the end of surgery: Levosimendan infusion will stop.
- Approximately 4 hours after surgery immediately before extubation.
- Approximately 21 hours after surgery
- Approximately 96 hours after surgery (day 4)
- 6 months after surgery
Outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.
Interim analysis will be conducted after 30 included patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levosimendan | Experimental | Drug: levosimendaninfusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation |
| Placebo | Placebo comparator | Drug: placebo drugIdentical placebo |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible for aortic valve replacement
- EF > 45%
- Left ventricular posterior wall > 12mm
- Sinus rhythm
Key exclusion criteria (9 listed)
- Concomitant bypass operation
- Severe mitral insufficiency
- Active endocarditis
- Insufficient ultrasound opportunity
- Systolic blood pressure < 100 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levosimendanAlso: SimdaxIntravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation. | Drug | levosimendan |
| placebo drugAlso: PlaceboIntravenous infusion, colour identical to levosimendan | Drug | Placebo |
Primary outcome
E/E'(Unitless)
Time frame: 4 hours before operation until 21 hour after operation
Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function
77 secondary outcomes
Isovolumetric Relaxation Time (IVRT) (s)
Time frame: 4 hours before surgery until 1 hour before operation
Ejection Fraction (Per Cent)
Time frame: At start of operation until end of operation, approximately 3 hours
Cardiac Index (l/Min/m2)
Time frame: 4 hours before operation until 1 hour before operation
Central Venous Pressure (mmHg)
Time frame: 4 hours before operation until 1 hours before operation
Pulmonary Artery Pressures (mmHg)
Time frame: 4 hours before operation until 1 hour before operation
Systemic Arterial Pressure (mmHg)
Time frame: 4 hours before operation until 1 hour before operation
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
Time frame: 4 hours before operation until 4 hours after operation
Troponin T (ug/l)
Time frame: 4 hours before operation until 4 hours after operation
Lactate (mmol/l)
Time frame: 4 hours before operation until 4 hour after operation
Mixed Venous Oxygenation (Per Cent)
Time frame: 4 hours before operation until 4 hour after operation
E/A Ratio (Unitless)
Time frame: At the start of operation until the end of operationon, approximately 3 hours
Regional Longitudinal Strain (Unitless)
Time frame: At the start of operation until the end of operation, approximately 3 hours
Need for Conventional Inotropical Agents
Time frame: From start of operation until 5 days after operation
Intravenous Fluid Requirement (l)
Time frame: Within 24 hours from start of operation
Operation Time (Minutes)
Time frame: From "knife start" until "knife end", approximately 3 hours
Time on Heart-lung Machine (Minutes)
Time frame: From time of cardioplegia until selfsufficient cardiac action, approximately 1 hour
Intubation Time (Minutes)
Time frame: From intubation until extubation, approximately 6 hours
Postoperative Admission Time at Intensive Care Unit (Hours)
Time frame: From admission to the intensive care unit until discharge from intensive care unit, approximately 24 hours
No. of Patients With Adverse Events
Time frame: -4 hours until + 96 hours with respect to start of operation
No. of Patients With Adverse Event
Time frame: -4 hours until + 96 hours with respect to start of operation
No. of Patients With Adverse Event
Time frame: 4 hours before operaton until 1 hour before operaton
No. of Patients With Adverse Event.
Time frame: 4 hours before operation until 1 hour before operation
No. of Patients With Adverse Event
Time frame: 4 hours before operation until approximately 1 hour before operation
Regional Longitudinal Strain (Unitless)
Time frame: 4 hours before until 1 hour before start of operation
Ejection Fraction (Per Cent)
Time frame: 1 hour before until 21 hour after start of operation
Ejection Fraction (Per Cent)
Time frame: 21 hours after operation until 96 hours after start of operation
Ejection Fraction (Per Cent)
Time frame: 96 hours after operation until 6 months after operation
Regional Longitudinal Strain (Unitless)
Time frame: Froml the end of operation until approx 4 hours after operation
E/A Ratio (Unitless)
Time frame: At the end of operationon until approx 4 hours after operation
Left Ventricular Rotation (Degrees)
Time frame: 96 hour after operation until 6 months after operation
Mixed Venous Oxygenation (Per Cent)
Time frame: 4 hours after operation until 21 hours after operation
Lactate (mmol/l)
Time frame: 4 hours after operation until 21 hours after operation
Troponin T (ug/l)
Time frame: 4 hours after operation until 21 hours after operation
Troponin T (ug/l)
Time frame: 21 hours after operation until 96 hours after operation
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
Time frame: 4 hours after operation until 21 hours after operation
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
Time frame: 21 hours after operation until 96 hours after operation
Systemic Arterial Pressure (mmHg)
Time frame: 1 hour before operation until start of operation
Systemic Arterial Pressure (mmHg)
Time frame: Start of operation until the end of operation, approximately 3 hours
Systemic Arterial Pressure (mmHg)
Time frame: End of operation until approx 4 hours after operation
Systemic Arterial Pressure (mmHg)
Time frame: 4 hours after operation until 21 hours after operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Juhl-Olsen, M.D. principal investigator
Department of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levosimendan in people with Diastolic Dysfunction and Left Ventricular Hypertrophy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
E/E'(Unitless) (time frame: 4 hours before operation until 21 hour after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.